Mediterranean Enriched Diet for Tackling Youth Obesity
NCT04719052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2024-10-30
Summary
The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours.
It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ≥90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021.
The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ≥95 percentile (obesity) and a caloric restriction \<20% of the total energy requirements will be applied in adolescents with BMI ≥90 to \<95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.
Conditions
- Obesity, Adolescent
- Lifestyle, Healthy
- Diet, Healthy
- Cardiovascular Risk Factor
Interventions
- OTHER
-
Diet and behavioural intervention
Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet
- OTHER
-
Diet and behavioural intervention
Control group will receive a specific diet designed following the characteristics of Low fat Diet.
Sponsors & Collaborators
-
University of Parma
collaborator OTHER -
University of Coimbra
collaborator OTHER -
Hospital Universitari Sant Joan de Reus
collaborator OTHER -
Fundació Eurecat
lead OTHER
Principal Investigators
-
Antoni Caimari, PhD · Eurecat-Reus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-05-25
- Primary Completion
- 2023-10-09
- Completion
- 2023-11-28
Countries
- Spain
Study Locations
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